Impella devices: a comprehensive review of their development, use, and impact on cardiogenic shock and high-risk percutaneous coronary intervention

ABSTRACTIntroduction Impella devices have emerged as a critical tool for temporary mechanical circulatory support (TMCS) in the management of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (PCI). The purpose of this review is to examine the history of the different Impella devices, their hemodynamic profiles, and how the data supports their use.Areas Covered This review covers the development and specifications of the Impella 2.5, Impella CP, Impella 5.0/Left Direct (LD), Impella RP, and Impella 5.5 devices. This review also covers the clinical trials that illuminate the Impella devices’ use in their appropriate clinical contexts. These studies examine the effectiveness of Impella devices and have begun to yield promising results, demonstrating improved survival rates when compared to the historically high mortality rates associated with CS. It is important to weigh the benefits of Impella devices in light of their contraindications. A literature search was conducted by searching the PubMed database for reviews, meta-analyses, and clinical trials pertinent to Impella devices.Expert Opinion Impella devices are a crucial tool for management of patients undergoing high-risk PCI and those with CS. There is evidence that early Impella implantation is beneficial in the treatment of patients presenting with CS. Further randomized controlled trials are needed to better elucidate the benefits of Impella devices in various clinical settings.KEYWORDS: Impellamechanical circulatory supportcardiogenic shockhigh-risk percutaneous coronary interventionheart failure Article highlights The Impella’s first iteration, the Impella 2.5, was FDA approved in 2008 for temporary mechanical circulatory support.Impella devices deliver between 2.5 L/min and 5.5 L/min of flow by drawing blood from the left ventricle and into the aorta, increasing cardiac output and mean arterial pressure.The Protect II trial, the first randomized controlled trial studying Impella devices, found that Impella provides a significant reduction in major adverse events and a significant increase in cardiac power output when compared to intra-aortic balloon pump in high-risk percutaneous coronary intervention.The Impella was first approved for cardiogenic shock secondary to acute myocardial infarction in 2016 based on data from the USpella registry which showed that Impella implantation prior to percutaneous coronary intervention caused a significant reduction in mortality in acute myocardial infarction-cardiogenic shock.The Detroit Cardiogenic Shock initiative revealed that early Impella implantation greatly increased the survival rate of acute myocardial infarction-cardiogenic shock compared to baseline cardiogenic shock mortality rates.Future randomized controlled trials such as the DanGer Shock Trial will further elucidate whether Impella use significantly improves survival in cardiogenic shock.Declaration of interestThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.Reviewer disclosuresA peer reviewer on this manuscript has received honoraria from Abiomed. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.Additional informationFundingThis paper was not funded.